The FINN study

Prof Lore Decoster, a medical oncologist at UZ-Brussels, presented an analysis of the FINN study, a real-world prospective investigation into the combination of ipilimumab and nivolumab, often referred to as the 9LA regimen, in the treatment of metastatic NSCLC. This German study enrolled a substantial number of patients with characteristics similar to those in the 9LA trial. Notably, they included patients with various levels of PD-L1 expression, although the analysis primarily focused on PD-L1 expression lower than 1% or more than 1%.

It’s worth noting that the study did not provide specific data on the number of patients with high PD-L1 expression, i.e., more than 50%. Intriguingly, approximately 24% of patients lacked PD-L1 expression data, which the researchers attributed to potential data collection issues that might be resolved as the dataset matures and is corrected. At the ESMO conference, the presentation primarily covered safety data, which revealed a noteworthy aspect. The safety profile appeared quite favourable, with relatively low rates of adverse events. Around 60% of patients experienced all-grade adverse events, and approximately 20% encountered grade 3 or 4 adverse events.

These figures were notably lower than those reported in the 9LA study, which is somewhat unexpected for a real-world study, as such studies often indicate higher adverse event rates compared to registration trials. Additionally, the study documented a limited number of immune-related adverse events, approximately 25-26%, which appeared to be less frequent than what was typically observed in the 9LA study. It’s generally believed that the combination of ipilimumab and nivolumab is associated with a higher incidence of immune-related adverse events. Prof Decoster raised some concerns about potential underreporting, particularly regarding endocrine adverse events, such as thyroid issues, as systematic testing for thyroid function wasn’t part of the study’s protocol.

Despite these considerations, the study is considered valuable, and the audience eagerly anticipates the release of efficacy data. Of particular interest is the performance of the treatment in both PD-L1 negative and PD-L1 positive patients. In Belgium, the regimen is more commonly used for PD-L1 negative NSCLC, and early impressions suggest a somewhat higher incidence of toxicity in this patient group.